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Rosemont Pharmaceuticals have developed over 90 oral liquid formulations
of medicines, successfully positioning itself as ‘The Specialists in Oral
Liquid Medicines’. Rosemont’s
manufacturing facilities are built for the production of oral liquid
preparations from simple liquids through to suspensions covering a broad
range of therapeutic areas. These
liquids are used to treat patients who, either because of medical
conditions or personal preference, take their medication in oral liquid
form.
Following the guidelines of the FDA’s 21 CFR Part 11, Rosemont
have approximately 4000 controlled documents ranging from methods of
manufacture, to standard operating procedures. Through documenting a vast amount of
information from other sources, the number of documents requiring control
at Rosemont is always rising, along with an increase in the different types
of documents, such as engineering drawings.
Rosemont Pharmaceuticals were therefore seeking a cost
effective way of controlling the creation, modification, issue and expiry
of documents within their organisation.
They also wanted to make company knowledge easily available to the
appropriate staff, and replace the databases where the data was fairly
static.
John Wyke, ???? at Rosemont, therefore began looking at a
number of software solutions that would help the company achieve these
goals. Operating in quite a high
margin, many of the software solutions that were advertised as specifically
pharmaceutical would satisfy their requirements, but at quite a high price. The competitive pricing of the Powerway
solution, coupled with the fact that Powerway offers a range of solutions
in a variety of modules, meant that Rosemont could deploy a cost effective
solution that would meet their current requirements, and potentially assist
them in other areas at a later time.
“The modular nature of the system means that we validated the
base functionality and document management functions,” remarks John. “We can then add other modules as we
need, validating the additional functions as we go.”
Rosemont will be using the system in a heavily prescribed
manner for their GMP documentation.
John believes that the Powerway solution will save time, and
therefore money, in document reviews, the maintenance of their paper
documents, and locating the information that their employees need. Once the non-GMP side of the system is
also deployed, and departments are responsible for their own documentation,
John believes that further time and cost savings will be realised in the
time taken to locate and retrieve vital information. John also believes that the Powerway
solution will help Rosemont Pharmaceuticals move towards being a knowledge
based organisation.
For pharmaceutical companies looking at document control
solutions, the requirements of CFR 21 Part 11 are of vital importance. “Systems are not compliant with Part 11
out of the box,” says John, “they must provide the appropriate
functionality to allow them to be used in a compliant manner.” To begin, the Powerway system was
validated following the GAMP V model, and undertaking User Acceptance
Testing which was linked to the User Requirements and included Part
11. All other requirements for
validation were demonstrated during an audit at Powerway’s head office in Indianapolis.
The ability to generate accurate copies of records is a core
functionality of the Powerway system, and the ability to set differing
levels of authority will satisfy the requirements for using authority
checks. Powerway also satisfies the
limiting of system access by allowing six different access levels on a
document-by-document basis, and prevents the approval of documents without
first opening the document. Use of
Powerway’s User Verification Utility, which prompts the user to re-enter
their password upon approval further assures the use of operational checks
to enforce sequencing.
Powerway also provides full document lifecycle management,
including full history which retains previous draft and approved versions
of all documents. Powerway’s
Document Manager then assures that only the most current version of the
document is available to users of the system. The security of Powerway on a qualified
secure pharmaceutical IT network will then meet the ‘Protection of Records’
requirements of Part 11. Finally,
Powerway demonstrated the ability for full training of the solution,
allowing Rosemont to ensure appropriate training and experience for all
users of the Powerway system.
For all organisations looking at software to help improve their
document control, it is essential that the solution is easy for employees
to use. One of the appeals of
Powerway to John Wyke was the simplicity of the Powerway interface:
“It was an easy sell to people who are wary of anything more
complicated that Microsoft Word as there aren’t many buttons or options for
them. They get documents; they get
what they need to see; they get told when it’s updated. They can find things easily, and that’s
the biggest selling point of the Powerway system.”
Rosemont Pharmaceuticals Ltd. is a
leading developer, manufacturer and marketer of high quality oral liquid
medicines. Based in Leeds, West Yorkshire, Rosemont employs approximately 130
people. It is a UK based, pharmaceutical subsidiary of the NASDAQ listed
company, SAVIENT Pharmaceuticals Inc.
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